Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

Last updated: May 2, 2025
Sponsor: Arthrosi Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Collagen Vascular Diseases

Gout (Hyperuricemia)

Treatment

AR882 75 mg

AR882 50 mg

Placebo

Clinical Study ID

NCT06846515
AR882-301
  • Ages 18-85
  • All Genders

Study Summary

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of gout

  • Occurrence of ≥ 2 self-reported gout flares in the last 12 months

  • Body weight no less than 50 kg

  • Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7mg/dL

  • Patients who are on medically appropriate ULT must have sUA > 6 mg/dL

  • Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 30 mL/min

Exclusion

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cellcarcinoma of the skin

  • Pregnant or breastfeeding

  • History of symptomatic kidney stones within the past 6 months

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: AR882 75 mg
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Arthrosi Investigative Site (620)

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Arthrosi Investigative Site (616)

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (629)

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Arthrosi Investigative Site (640)

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Arthrosi Investigative Site (617)

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (614)

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (618)

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (655)

    La Palma, California 90623
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (632)

    Lincoln, California 95648
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (605)

    Lomita, California 90717
    United States

    Site Not Available

  • Arthrosi Investigative Site (675)

    Long Beach, California 90806
    United States

    Site Not Available

  • Arthrosi Investigative Site (603)

    Santa Monica, California 90404
    United States

    Site Not Available

  • Arthrosi Investigative Site (672)

    Tarzana, California 91356
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (656)

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (630)

    Tujunga, California 91042
    United States

    Site Not Available

  • Arthrosi Investigative Site (667)

    Whittier, California 90602
    United States

    Site Not Available

  • Arthrosi Investigative Site (660)

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (669)

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Arthrosi Investigative Site (612)

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (665)

    Cooper City, Florida 33024
    United States

    Site Not Available

  • Arthrosi Investigative Site (613)

    Jupiter, Florida 33458
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (611)

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (644)

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (615)

    Sanford, Florida 32771
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (600)

    Tampa, Florida 33609
    United States

    Site Not Available

  • Arthrosi Investigative Site (673)

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (652)

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (658)

    Honolulu, Hawaii 96814
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (676)

    Boise, Idaho 83713
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (634)

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (657)

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (648)

    Melrose Park, Illinois 60160
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (678)

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (679)

    Overland Park, Kansas 66209
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (674)

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (627)

    Mandeville, Louisiana 70471
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (650)

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (641)

    Prairieville, Louisiana 70769
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (662)

    Oxon Hill, Maryland 20745
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (653)

    Rockville, Maryland 20852
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (636)

    Fall River, Massachusetts 02721
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (622)

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (628)

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Arthrosi Investigative Site (645)

    Southfield, Michigan 48076
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (633)

    Gulfport, Mississippi 39503
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (635)

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (637)

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Arthrosi Investigative Site (626)

    Town and Country, Missouri 63017
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (610)

    Lincoln, Nebraska 68516
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (651)

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (661)

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (663)

    Hartsdale, New York 10530
    United States

    Site Not Available

  • Arthrosi Investigative Site (625)

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (683)

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (649)

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (666)

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (671)

    Mason, Ohio 45040
    United States

    Site Not Available

  • Arthrosi Investigative Site (631)

    Norman,, Oklahoma 73072
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (642)

    Tulsa, Oklahoma 74133
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (647)

    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (623)

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Arthrosi Investigative Site (638)

    Charlston, South Carolina 29407
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (604)

    Fort Mill, South Carolina 29707
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (608)

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (619)

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (624)

    Hendersonville, Tennessee 37075
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (670)

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Arthrosi Investigative Site (677)

    Austin, Texas 78735
    United States

    Site Not Available

  • Arthrosi Investigative Site (639)

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (601)

    Houston, Texas 77074
    United States

    Site Not Available

  • Arthrosi Investigative Site (607)

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (646)

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (659)

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (643)

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (609)

    Salt Lake City, Utah 84121
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (654)

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Arthrosi Investigative Site (606)

    Charlottesville, Virginia 29911
    United States

    Active - Recruiting

  • Arthrosi Investigative Site (668)

    Kenosha, Wisconsin 53144
    United States

    Active - Recruiting

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